| Primary Device ID | 53760087123970 |
| NIH Device Record Key | 40d6f5f4-cc38-4125-b46d-b1137e679908 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ophthalmic trocar |
| Version Model Number | RETILOCK® 25G NON VALVED SELF-RETAINING TROCAR |
| Catalog Number | S9.7000.25 |
| Company DUNS | 763408366 |
| Company Name | FCI S A S FCI 20 22 |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-932-4202 |
| orders@fci-ophthalmics.com |
| Needle Gauge | 25 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760087123975 [Primary] |
| GS1 | 53760087123970 [Unit of Use] |
| NGY | Cannula, Trocar, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[53760087123970]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-04 |
| Device Publish Date | 2020-02-25 |
| 53760087123987 | A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture |
| 53760087123970 | A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture |
| 53760087123871 | A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture |
| 53760087123888 | A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture |